RecruitingPhase 1NCT06821685

Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

14 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Pre-Eclampsia Abortion, Habitual Infertility Unexplained Embryo Implantation

Summary

The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.

Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 40 Years

Inclusion Criteria6

abnormal uterine NK cell function;
have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
have clear fertility desires;
normal ovarian function or with frozen embryos;
edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase \>= 7mm;
kg/m\^2 \< Body mass index \< 30kg/m\^2;

Exclusion Criteria8

using progesterone receptor modulator;
chromosomal karyotype abnormalities in one spouse;
severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
uncontrolled autoimmune diseases;
abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
history of pelvic malignant tumors;
currently participating in other clinical studies;
allergic to blood products.

Interventions

BIOLOGICALautologous decidual-like NK cells

intrauterine infusion

Locations(1)

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

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